Colonic Diverticuar DiseaseEIMAPNCT06506552
Effects of Inferior Mesenteric Artery Preservation in Laparoscopic Colorectal Resection for Diverticular Disease.
A study testing IMA preserving and IMA sectioning in people with Colonic Diverticuar Disease and Defecatory Functions, run by University of Roma La Sapienza.
Trial summary
This is a prospective randomized study aimed to verifying the short and long-term results of inferior mesenteric artery preservation following colorectal resection for diverticular disease Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colonic Diverticuar Disease, Defecatory Functions, Fecal Incontinence
- What is being tested?
- IMA preserving and IMA sectioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 20 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI \< 35
- ASA I-III
- Hinchey I-III
Who cannot join
- BMI \> 35
- ASA IV
- Hinchey IV
- Previous procedures that could have been modified the nervous mesenteric pattern (surgery, radiotherapy or chemotherapy)
About this study
Official title: Inferior Mesenteric Artery Preservation in Laparoscopic Colorectal Resection for Diverticular Disease; Short and Long Term Effects in Defecatory Function
This is a prospective randomized study aimed to verifying the short and long-term results of inferior mesenteric artery preservation following colorectal resection for diverticular disease
Read the detailed description
This study wants to demonstrate that the preservation of the inferior mesenteric artery allow to improve postoperative defecatory function and improve patient\'s quality of life.
- Being tested
- IMA preserving, IMA sectioning
- Keywords
- defecatory function, anterior resection syndrome, constipation, diverticular disease, fecal incontinence, fragmented evacuation
- Medical subject headings
- Fecal Incontinence, Constipation, Diverticular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMA preservingProcedure or surgery
Performing left hemicolectomy, sigmoidectomy or rectal resection the IMA was preserved ligating the sigmoids arteries close to the colonic wall
IMA sectioningProcedure or surgery
Performing left emicolectomy, sigmoidectomy or rectal resection the IMA is sectioned after the origin of left colic artery.
| Study group | Role | What they receive |
|---|---|---|
| Inferior mesenteric artery preservation | Experimental | Performing colorectal resection for diverticular disease the IMA was preserved ligating the sigmoids arteries close to colonic wall. Receives: Procedure: IMA preserving |
| Inferior mesenteric ligation | Active comparator | Performing colorectal resection the IMA was sectioned just below the origin of left colic artery. Receives: Procedure: IMA sectioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defecatory disorders
the presence of defecatory disorders was evaluated (Costipation, Evacuation frequency,evacuation urgency, fragmented evacuation,flatus incontinence, liquid incontinence)
Measured: 6 months from surgery
Defecatory disorders
the presence of defecatory disorders was evaluated (Costipation, Evacuation frequency,evacuation urgency, fragmented evacuation,flatus incontinence, liquid incontinence)
Measured: 12 months from surgery
Defecatory disorders
the presence of defecatory disorders was evaluated (Costipation, Evacuation frequency,evacuation urgency, fragmented evacuation,flatus incontinence, liquid incontinence)
Measured: 6 years from surgery
Secondary outcomes (18)
Constipation
The incidence and severity of postoperative constipation was evaluated with Cleveland Clinic Constipation Score ( score range from 0 to 30, the higher score defines worse constipation status)
Measured: 6 months from surgery
Constipation
The incidence and severity of postoperative constipation was evaluated with Cleveland Clinic Constipation Score ( score range from 0 to 30, the higher score defines worse constipation status)
Measured: 12 months from surgery
Constipation
The incidence and severity of postoperative constipation was evaluated with Cleveland Clinic Constipation Score ( score range from 0 to 30, the higher score defines worse constipation status)
Measured: 6 years from surgery
Incontinence
The presence of fecal incontinence was evaluated with Cleveland Clinic Incontinence Score( score range from 0 to 20, the higher score defines worse symptoms)
Measured: 6 months from surgery
Incontinence
The presence of fecal incontinence was evaluated with Cleveland Clinic Incontinence Score( score range from 0 to 20, the higher score defines worse symptoms)
Measured: 12 months from surgery
Incontinence
The presence of fecal incontinence was evaluated with Cleveland Clinic Incontinence Score( score ranges from 0 to 20, the higher score defines worse symptoms)
Measured: 6 years from surgery
Anorectal Muscles function
The anorectal muscles function was evaluated with anorectal manometry( sphincter lenght, maximum squeeze pression, resting anal pressure, squeeze duration, maximum pressure sustained)
Measured: 6 months from surgery
Anorectal Muscles function
the anorectal muscles function was evaluated with anorectal manometry ( sphincter lenght, maximum squeeze pression, resting anal pressure, squeeze duration, maximum pressure sustained)
Measured: 6 years from surgery
Postoperative quality of life
the postoperative QOL(quality of life) was evaluated with EORTC-30 tests( European organization for research and treatment of cancer, scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms)
Measured: 6 months from surgery
Postoperative quality of life
the postoperative QOL was evaluated with EORTC-30 tests( European organization for research and treatment of cancer,scores range from 0 to 100; a higher score represents a higher "better" level of functioning, or a higher "worse" level of symptoms
Measured: 12 months from surgery
Postoperative quality of life
The postoperative QOL was evaluated with EORTC-30 tests( European organization for research and treatment of cancer,scores range from 0 to 100; a higher score represents a higher "better" level of functioning, or a higher "worse" level of symptoms)
Measured: 6 years from surgery
Postoperative quality of life
The postoperative QOL was evaluated with EORTC-29 tests (European organization for research and treatment of cancer each question goes from 1 to 4 , the higher score defines worse symptoms)
Measured: 12 months from surgery
Postoperative quality of life
The postoperative QOL was evaluated with EORTC-29 tests (European organization for research and treatment of cancer each question goes from 1 to 4 , the higher score defines worse symptoms)
Measured: 6 years from surgery
Postoperative quality of life
The postoperative QOL was evaluated with EORTC-29 tests (European organization for research and treatment of cancer each question goes from 1 to 4 , the higher score defines worse symptoms)
Measured: 6 months from surgery
Postoperative quality of life
The postoperative QOL(quality of life) was evaluated with SF-36 score (Short form-36 score, each item scored from 0 to 100, the higher scores defines a favorable health state)
Measured: 6 months from surgery
Postoperative quality of life
The postoperative QOL was evaluated with SF-36 score (Short form-36 score, each item scored from 0 to 100, the higher scores defines a favorable health state)
Measured: 12 months from surgery
Postoperative quality of life
The postoperative QOL was evaluated with SF-36 score (Short form-36 score, each item scored from 0 to 100, the higher scores defines a favorable health state)
Measured: 6 years from surgery
Postoperative surgical complication
The incidence of postoperative surgical complications was evaluated
Measured: 1 month from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Jan 2012
- Primary completion15 Jan 2024
- Study completion20 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonic Diverticuar DiseaseStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Saverio Mari, MD, PhD, FACS, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506552
- Sponsor's protocol ID
- DS-056
- Acronym
- EIMAP
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mari FS, Chiarini L, Trampetti L, Savina C, Cosmi F, Cicolani A, Gasparrini M, Brescia A. Preservation of inferior mesenteric artery reduces short- and long-term defecatory dysfunction after laparoscopic colorectal resection for diverticular disease: An RCT. Surg Endosc. 2025 Mar;39(3):1761-1769. doi: 10.1007/s00464-024-11490-7. Epub 2025 Jan 15.
PubMed 39814952
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inferior Mesenteric Artery Preservation in Laparoscopic Colorectal Resection for Diverticular Disease; Short and Long Term Effects in Defecatory Function
- ClinicalTrials.gov ID
- NCT06506552
- Acronym / sponsor ID
- EIMAP / DS-056
- Keywords
- defecatory function, anterior resection syndrome, constipation, diverticular disease, fecal incontinence, fragmented evacuation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 20 Jan 2024 (actual)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective randomized study aimed to verifying the short and long-term results of inferior mesenteric artery preservation following colorectal resection for diverticular disease
Detailed description
This study wants to demonstrate that the preservation of the inferior mesenteric artery allow to improve postoperative defecatory function and improve patient\'s quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inferior mesenteric artery preservation | Experimental | Procedure: IMA preservingPerforming colorectal resection for diverticular disease the IMA was preserved ligating the sigmoids arteries close to colonic wall. |
| Inferior mesenteric ligation | Active comparator | Procedure: IMA sectioningPerforming colorectal resection the IMA was sectioned just below the origin of left colic artery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI \< 35
- ASA I-III
- Hinchey I-III
Key exclusion criteria (4 listed)
- BMI \> 35
- ASA IV
- Hinchey IV
- Previous procedures that could have been modified the nervous mesenteric pattern (surgery, radiotherapy or chemotherapy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMA preservingPerforming left hemicolectomy, sigmoidectomy or rectal resection the IMA was preserved ligating the sigmoids arteries close to the colonic wall | Procedure or surgery | Inferior mesenteric artery preservation |
| IMA sectioningPerforming left emicolectomy, sigmoidectomy or rectal resection the IMA is sectioned after the origin of left colic artery. | Procedure or surgery | Inferior mesenteric ligation |
Primary outcome
Defecatory disorders
Time frame: 6 months from surgery
the presence of defecatory disorders was evaluated (Costipation, Evacuation frequency,evacuation urgency, fragmented evacuation,flatus incontinence, liquid incontinence)
Defecatory disorders
Time frame: 12 months from surgery
the presence of defecatory disorders was evaluated (Costipation, Evacuation frequency,evacuation urgency, fragmented evacuation,flatus incontinence, liquid incontinence)
Defecatory disorders
Time frame: 6 years from surgery
the presence of defecatory disorders was evaluated (Costipation, Evacuation frequency,evacuation urgency, fragmented evacuation,flatus incontinence, liquid incontinence)
18 secondary outcomes
Constipation
Time frame: 6 months from surgery
Constipation
Time frame: 12 months from surgery
Constipation
Time frame: 6 years from surgery
Incontinence
Time frame: 6 months from surgery
Incontinence
Time frame: 12 months from surgery
Incontinence
Time frame: 6 years from surgery
Anorectal Muscles function
Time frame: 6 months from surgery
Anorectal Muscles function
Time frame: 6 years from surgery
Postoperative quality of life
Time frame: 6 months from surgery
Postoperative quality of life
Time frame: 12 months from surgery
Postoperative quality of life
Time frame: 6 years from surgery
Postoperative quality of life
Time frame: 12 months from surgery
Postoperative quality of life
Time frame: 6 years from surgery
Postoperative quality of life
Time frame: 6 months from surgery
Postoperative quality of life
Time frame: 6 months from surgery
Postoperative quality of life
Time frame: 12 months from surgery
Postoperative quality of life
Time frame: 6 years from surgery
Postoperative surgical complication
Time frame: 1 month from surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Derived from this study: PubMed 39814952Mari FS, Chiarini L, Trampetti L, Savina C, Cosmi F, Cicolani A, Gasparrini M, Brescia A. Preservation of inferior mesenteric artery reduces short- and long-term defecatory dysfunction after laparoscopic colorectal resection for diverticular disease: An RCT. Surg Endosc. 2025 Mar;39(3):1761-1769. doi: 10.1007/s00464-024-11490-7. Epub 2025 Jan 15.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing IMA preserving and IMA sectioning in people with Colonic Diverticuar Disease and Defecatory Functions, run by University of Roma La Sapienza.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Defecatory disorders (time frame: 6 months from surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06506552, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.